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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06875466




Registration number
NCT06875466
Ethics application status
Date submitted
9/03/2025
Date registered
25/03/2025

Titles & IDs
Public title
Exploring the Health Benefits of Sauna Bathing
Scientific title
Exploring the Health Benefits of Sauna Bathing - a Pilot Study
Secondary ID [1] 0 0
Sauna
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Pressure 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Sauna bathing

Experimental: Sauna Bathing - Participants receive the sauna bathing treatment (1 session per week for 8 weeks)


Treatment: Devices: Sauna bathing
Finnish sauna bathing, participants will sauna once per week for 8 weeks
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
24 hour ambulatory blood pressure
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Quality of life questionnaire
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
PROMIS Sleep Questionnaire
Timepoint [2] 0 0
8 weeks

Eligibility
Key inclusion criteria
* SBP: 110-179 mmHg; DBP 60-99 mmHg)
* 18 - 70 y old.
* Participants who are prescribed anti-hypertensive or dyslipidaemia medications will be included but must be on a stable dose for at least 30 days.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* stable or unstable angina
* recent myocardial infarction (<3 months)
* orthostatic hypotension
* severe aortic stenosis
* pregnancy
* acute infectious diseases
* rheumatoid arthritis in the acute inflammatory phase
* fever for any reason
* any other medical condition deemed a risk.

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Other
Name
The Centre for Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anna Rolleston, PhD
Address 0 0
The Centre for Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tasha Burton, MSc
Address 0 0
Country 0 0
Phone 0 0
0220180557
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06875466